FDA label c1985941-fe28-41ac-8582-4a1dd44928aa

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID: 2c30e0c9-f86b-4d01-8b74-82d3a0da3672
SPL ID: c1985941-fe28-41ac-8582-4a1dd44928aa
Version: 7
Effective date: 2019-01-03
Source export date: 2026-10-12
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:29:07

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		c1985941-fe28-41ac-8582-4a1dd44928aa	id
spl set id		2c30e0c9-f86b-4d01-8b74-82d3a0da3672	set_id

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS: Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Stop use and ask a doctor if cough persists for more than one (1) week, tends to recur, or if it is accompanied by fever, rash or by persistent headache. A persistent cough may be a sign of a serious condition. Keep out of reach of children . In case of overdose, get medical help or call a Poison Control Center right away. If pregnant or breast feeding , ask a doctor before using product. Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken. Other information Store at room temperature.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.